Chinese Biopharma Firms Including Innovent and Qilu Advance Pancreatic Cancer Therapies with Novel CLDN18.2-Targeted and TF-Targeted Agents Entering Pivotal Trials

　　【Pharmaceutical Network Industry DynamicsIn recent years, innovative drug companies in China have been actively deploying efforts in the field of pancreatic cancer treatment, continuously investing in research and development. Numerous achievements in innovative drug research have emerged, bringing new hope to patients with pancreatic cancer. Pancreatic cancer, known as the "king of cancers" due to its high malignancy as a digestive system tumor, has a 5-year survival rate of less than 10%. Most patients are diagnosed at an advanced stage, with rapid disease progression, limited treatment options, and poor outcomes, leading to a dire prognosis. Therefore, the development of new and effective therapeutic drugs is urgently needed.
 

A multicenter, randomized, double-blind, controlled Phase III study of Innovent Bio's IBI343 monotherapy combined with supportive care versus placebo combined with supportive care in subjects with Claudin (CLDN) 18.2-positive, locally advanced unresectable or metastatic pancreatic cancer who have previously received at least two lines of systemic therapy has been initiated. The initial information disclosure date is June 27, 2025.
 

The primary endpoint of this trial is overall survival; secondary endpoints include progression-free survival assessed according to RECIST v1.1 criteria, objective response rate, disease control rate, duration of response, time to response; subject's global health status assessed by scale; incidence of treatment-emergent adverse events, adverse events of special interest, and serious adverse events, their relationship to the study drug and severity, changes in vital signs, ECG, and laboratory test results before and after the study treatment; PK characteristics; positive rates of anti-IBI343 antibodies and/or neutralizing antibodies and the impact of ADA on safety, efficacy, and total antibody PK parameters; correlation between baseline CLDN18.2 expression levels and efficacy.
 

Xinnovis Pharma has also taken an important step in the research and development of pancreatic cancer treatment drugs. The Drug Clinical Trial Registration and Information Disclosure Platform recently showed that Xinnovis Pharma registered a Phase III clinical trial of XNW28012 Injection for pancreatic cancer. XNW28012 is a next-generation ADC targeting tissue factor (TF). This is a randomized, double-blind, multi-center Phase III clinical study designed to compare the efficacy and safety of XNW28012 or placebo combined with best supportive care in patients with metastatic pancreatic cancer who have previously received systemic therapy. The trial plans to enroll 150 participants, and the primary endpoint of the study is overall survival.
 

Qilu Pharmaceutical is also actively engaged in the research and development of innovative drugs for pancreatic cancer. The randomized, double-blind, multicenter Phase III clinical study evaluating QLS31905 Injection combined with chemotherapy versus placebo combined with chemotherapy for first-line treatment of CLDN18.2-positive advanced pancreatic cancer was announced for the first time on July 30, 2025. The primary endpoint of this trial is overall survival (OS); secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), duration of response (DoR), as well as the incidence and severity of adverse events/serious adverse events (SAE), abnormalities in vital signs, physical examinations, electrocardiograms, and laboratory test values.
 

Lepu Biopharma has also joined the race to tackle pancreatic cancer. Recently, the Drug Clinical Trial Registration and Information Platform announced that Lepu Biopharma has initiated a Phase III clinical trial of MRG004A for the treatment of pancreatic cancer. According to available information, MRG004A is a novel monoclonal antibody-drug conjugate (ADC) targeting tissue factor (TF), utilizing site-specific conjugation technology to enhance the drug's stability in the bloodstream. TF overexpression is associated with thrombosis, metastasis, and poor prognosis in solid tumors, including cervical and pancreatic cancer.
 

In addition, Hutchmed initiated a Phase 2/3 study in China, with the first public disclosure on March 18, 2024. The drug clinical trial registration and information disclosure platform showed that Hutchmed has launched a Phase II/III clinical study of surufatinib in combination with camrelizumab, nab-paclitaxel, and gemcitabine for the treatment of metastatic pancreatic cancer. The study aims to evaluate the safety and tolerability of surufatinib in combination with camrelizumab, nab-paclitaxel + gemcitabine (AG) as first-line treatment for metastatic pancreatic cancer, as well as the efficacy of surufatinib combined with camrelizumab and AG compared with AG alone as first-line treatment for metastatic pancreatic cancer.
 

These R&D achievements by innovative drug companies in China in the field of pancreatic cancer treatment have brought more treatment options and survival hope to patients with pancreatic cancer. As various clinical trials progress and deepen, it is expected that these innovative drugs will successfully reach the market, rewriting the current state of pancreatic cancer treatment and bringing better prognoses to patients. At the same time, it is also hoped that more companies will increase their R&D investment in the field of pancreatic cancer treatment, promoting continuous development and advancement in this area.
 

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